The following Structured Product Label (SPL) was submitted to the FDA by Prokpil Sas for the product Octisalate, Octocrylene, Octinoxate, Zinc Oxide, Titanium Dioxide, Ensulizole (NDC 71801-542). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding losanika aloe & calendula antioxidant sunscreen broad spectrum spf 30 - ensulizole 2.0 %, titanium dioxide 2.4 %, octocrylene 3.0 %, zinc oxide 3.5 %, octisalate 4.5 %, octinoxate 6.5 %, purpose:, active ingredients:, uses:, warning:, when using this product:, stop use and ask a doctor:, keep out of reach of children:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with
regulations and policies. FDA has not evaluated weather this product complies.
SUNSCREEN
ENSULIZOLE 2.0 %
TITANIUM DIOXIDE 2.4 %
OCTOCRYLENE 3.0 %
ZINC OXIDE 3.5 %
OCTISALATE 4.5 %
OCTINOXATE 6.5 %
the risk of skin cancer and early skin aging caused by the sun.
For external use only.
Do not use on damaged or broken skin.
Keep out of eyes.
Rinse with water to remove.
If rash or irritation develops or lasts.
If swallowed, get medical help or contact a Poison Control Center right away
Apply liberally 15 minutes before sun exposure
Use water resistant sun protector if swimming or sweating.
Reapply at least every two hours.
Children under six months: ask a doctor
Sun protection measures:
Overexposure to the sun is dangerous. Increases the risk of causing skin cancer and premature aging.
To reduce the risk, regularly use sunscreen with broad spectrum SPF 15 or higher, combined with other sun protection measures. Limit exposure time especially between 10 am - 2 pm. Wear long sleeves, hat and glasses.
Water (Aqua), Aloe vera (Aloe) Leaf juice, Calendula officinalis (calendula) flower extract, Aluminum Starch Octenylsuccinate,C12-15 Alkyl Benzoate, Propylheptyl Caprylate, Dicaprylyl Carbonate (and) Stearalkonium Hectorite (and) Propylene Carbonate, Cetearyl Alcohol, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Coffea arabica (Coffee) seed oil, Sodium Stearoyl Glutamate, Tocopheryl Acetate(E), Niacinamide (B3), Panthenol, Glycerin, Xanthan Gum, Fragrance, Phenoxyethanol (And) Decylene Glycol (And) Caprylyl Glycol, Bixa Orellana Seed Extract (Annato), Cymbopogon citratus (lemongrass) oil, Zingiber officinale (ginger) root oil, Citrus sinensis (sweet orange) peel oil, Lippia alba (bushy matgrass) leaf/stem oil.
Protect from excessive heat and direct sunlight.
Formulated without: parabens, silicones, mineral oils, synthetic dyes.
* Please review the disclaimer below.
